Monday, December 9, 1996
WASHINGTON - Congress, the executive branch and industry have set off on three paths that could lead to substantial changes by the end of 1997 in the way FDA regulates and interacts with the biotechnology and pharmaceutical industries.
By next spring, and perhaps sooner, a new FDA commissioner could take office with a mandate to modernize and streamline the agency; FDA and the biotech and pharmaceutical industries will likely have agreed on terms for re-authorizing the Prescription Drug User Fee Act and associated performance standards; and legislation will have been introduced in the House, and possibly the Senate, to cut drug development times while maintaining current safety standards.
These three streams will be closely intertwined, with progress in one shaping the course of the others, according to members of Congress and their staffs, White House officials and industry experts and policy analysts in Washington.
FDA Commissioner David Kessler's resignation took the Clinton administration by surprise, and the White House and Health and Human Services Secretary Donna Shalala have not yet initiated an organized process to identify a successor. Because of Kessler's success in attracting favorable media attention and garnering public support for his activities, the selection process will be subject to a high degree of public scrutiny and political attention.